Geo CMFit Abutment
- Primary DI
- 08800028712877
- Brand
- Geo CMFit Abutment
- Company
- GEOMEDI INC.
- Model
- CMFit14-SURO-H2
- Device description
- Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engagingconnections.
- Published
- 2025-06-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| NHA | Abutment, Implant, Dental, Endosseous |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K242978 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800028712877 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800028712877 | 08800028712877 | 8800028712877 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental implant suprastructure, permanent, preformed | A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 694173762
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08800028739935 | Geo ArcB Scanbody | ArcB-3025N | 2025-12-30 | |
| 08800028739942 | Geo ArcB Scanbody | ArcB-5017N | 2025-12-30 | |
| 08800028739911 | Geo ArcB Scanbody | ArcB-3017N | 2025-12-23 | |
| 08800028739928 | Geo ArcB Scanbody | ArcB-3021N | 2025-12-23 | |
| 08800028739959 | Geo ArcB Scanbody | ArcB-5021N | 2025-12-23 | |
| 08800028739966 | Geo ArcB Scanbody | ArcB-5025N | 2025-12-23 | |
| 08800028739973 | Geo Impression Direct Coping | IPDC-5055N | 2025-12-23 | |
| 08800028739980 | Geo Impression Direct Coping | IPDC-5070N | 2025-12-23 | |
| 08800028739997 | Geo ArcB Scanbody Analog | IMP-ArcB | 2025-12-23 | |
| 08800028740009 | Geo Screw Driver | SRDNBS | 2025-12-23 | |
| 08800028740016 | Geo Screw Driver | SRDNBR | 2025-12-23 | |
| 08800028740023 | Geo Screw Driver | SRDNBL | 2025-12-23 | |
| 08800028740030 | Geo Screw Driver | SLDNBS | 2025-12-23 | |
| 08800028740047 | Geo Impression Direct Coping | IPDC-5040N | 2025-12-23 | |
| 08800028740054 | Geo ArcB Scanbody Kit | ABSK-SET-B | 2025-12-23 | |
| 08800028740061 | Geo Screw | ArcB30NC | 2025-12-23 | |
| 08800028740078 | Geo Screw | ArcB30NC5 | 2025-12-23 | |
| 08800028740085 | Geo Screw | ArcB50NC | 2025-12-23 | |
| 08800028740092 | Geo Screw | ArcB50NC5 | 2025-12-23 | |
| 08800028739898 | Geo ArcB Scanbody Kit | ABSK-SET-A | 2025-12-18 |
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